Corporate Overview OTC QB: SVON OCTOBER 7, 2014
Safe Harbor Statement Certain statements included in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results could differ materially from such statements expressed or implied herein as a result of a variety of factors, including, but not limited to: the Company’s ability to integrate the Fabrus science and operations; the Company’s ability to continue as a going concern; the Company’s ability to recruit patients for its clinical trial; the ability of the Company to consummate additional financings; the development of the Company’s gene and antibody technology; the approval of the Company’s patent applications; the current uncertainty in the patent landscape surrounding small inhibitory RNA and the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company's license agreements; the acceptance by the market of the Company’s products; the timing and success of the Company’s preliminary studies, preclinical research and clinical trials; competition and the timing of projects and trends in future operating performance; and the quotation of the Company’s common stock on an over - the- counter securities market, as well as other factors expressed from time to time in the Company’s periodic filings with the Securities and Exchange Commission (the "SEC"). As a result, this press release should be read in conjunction with the Company’s periodic filings with the SEC. The forward -looking statements contained herein are made only as of the date of this press release, and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances. 1
About Sevion Therapeutics Clinical stage oncology and immunology company focused on the discovery, development and acquisition of innovative products Proprietary technology platforms – Cow antibody scaffold allows drugging of previously inaccessible targets – Arrayed Antibody discovery technology enables differentiated screening – eIF5A gene technology broadly regulates cell death and survival Platform validated by multiple first-in-class drug candidates and drug discovery collaborations with large pharma 108 issued patents (31 U.S., 77 foreign) with multiple pending applications Company leadership with a proven track record New corporate identity (formerly Senesco/Fabrus) 2
Multiple First-in-Class Therapeutics in Development Discovery Preclinical Phase 1 Phase 2 Phase 3 SNS01-T Oncology – MM, DLCBL (nanoparticle; eIF5A ) SVN-001 Autoimmune/Inflammation (Cow Antibody, Kv1.3) SVN-002 Oncology - RCC (Human Antibody) SVN-003 Oncology - RCC (Chimerasome; insulin receptor) Other Internal Targets Oncology (Antibodies; GPCRs, ion channels) Undisclosed* Oncology Undisclosed* Oncology * Collaboration: Sevion activities expected to begin Q4 2014 3
Sevion Therapeutics: Addressing the Problem with Current Antibodies Only a small Current Technology Sevion Technology fraction of Soluble Proteins Membrane Proteins potential targets are effectively addressed with current antibody technology (hybridoma, display) (i.e. TNFa) Sevion employs two approaches to drugging novel targets Cow antibodies Arrayed libraries 4
Novel Cow Antibody Platform Ultra long CDR3 antibodies Unique ultra long structure enables are unique to cows binding to otherwise intractable targets (such as crevices, pores, channels, or other targets that “regular” antibodies cannot) Humanization of the cow scaffold enables therapeutic use Novel intellectual property on composition of cow antibodies and humanization (in-licensed from Scripps and internal) Wang et.al. (2013) Cell 153: 1379-1393 5
Arrayed Antibody Discovery: Small Molecule Paradigm Applied to Antibodies DNA – human genome project Bioinformatics High-throughput gene synthesis High-throughput, parallel protein production Fundamentally differentiated from phage display and hybridoma technologies IgG format - manufacturing Cell surface screening Faster, more relevant hits Unique activities Tens of thousands of antibodies 6
Proprietary Cell Surface Antibody Discovery High throughput cell sorting (FACS) allows us to rapidly screen multiple targets simultaneously directly on the cell 7
Antibody Discovery Leveraged for Internal Portfolio and Collaborations Proprietary enabling platform for internal Validated Platform pipeline development, lead discovery Generated antibodies to over for out-licensing, and drug discovery 25 targets collaborations Antagonist and modulator antibodies Pharma validation: BMS - discovery discovered and engineered against GPCR targets of antibodies against two GPCR targets in oncology Unique antibodies/epitopes against Additional collaborations pending common targets like Her2, and ErbB3 identified Novel cow scaffold engineered and validated against an ion channel (Kv1.3) with pM range activity Composition of matter and use patent claims on SVN001 and SVN002 8
SVN001: First in Class Kv1.3 Antibody for Autoimmune Diseases Kv1.3 is a novel ion channel critical for T-cell activation Plays critical role in modulating activity of effector memory T-cells (TEM) T-cell activation plays a role in autoimmune disease: arthritis, psoriasis, IBD, GVHD, MS and others Scorpion venom treatment effect on MS (Lancet 2:1021 (1983)) later shown to be due to blockade of the Kv1.3 Venom/bioactive peptide ion channel Sevion has developed a novel cow antibody with the efficacy attributes of venom but with half-life, stability, and dosing attributes of an antibody 9
Why SVN001 Will Have High Impact Safety – Intact Immune System: Selective Inhibition of T-cell activation against TEM cells, T-cell compartment remains by a humanized cow antibody intact, leaving the immune system capable of fighting infections. Limitations of current 0.6 therapies are related to AE’s due to broad immunosuppression 0.45 ec 50 =0.2nM Ultra Potent: pM IC50’s in human blood and T-cell activation assays TNFa (A450, sem) 0.3 Half-Life: IgG Fc region affords long t1/2 (potential once a month SQ dosing) Medical Need: More than a third of patients 0.15 across all indications are non-responsive to anti-TNF treatments 0 0.001 0.01 1 10 100 1000 Novel MOA/Reversible: Inhibiting the Kv1.3 target suppresses multiple key inflammatory (nM) cytokines. Anti-Kv1.3 inhibition is effective after T-cell activation and is reversible 10
SVN002: Unique Target for Renal Cell Carcinoma SVN002 binds to a target (currently undisclosed) which is highly expressed in Clear Cell Renal Carcinoma. Target is associated with blood vessel sprouting/angiogenesis, independent of VEGF and is associated with poor prognosis in ccRCC May solve anti-VEGF resistance, which occurs in all ccRCC metastatic patients Colored urogram (X-ray) of the left kidney of a patient with renal clear cell carcinoma (blue). Credit: Sovereign, ISM/Science Photo Library 11
SVN002: Target Inhibition Reduces Growth as a Single Agent in a ccRCC Xenograft Model 600” PBS 500” Antibody 400” Tumor Volume (mm3) PBS Antibody 300” 200” Treatment 100” 0” 0 5 10 15 20 25 30 35 Days Preclinical studies for this program are support by collaborations with University of North Carolina Cancer Center 12
Sevion Technology Expands Opportunity for MAbs Most Targets Cannot be Addressed by Current Modalities Our Target Market GPCRs Antibodies against membrane targets Novel approach to enable Ion Channels TNF IgE VEGF Soluble Proteins Pores/Pumps Extracellular Current Antibody Market Domains Her2 Hybridoma & display platforms EGFR Multiprotein Complexes CTLA4 Restricted to soluble and extracellular domains Posttranslational Modifications Inability to make purified antigen Sulfation and immune restriction Non-Protein Targets Glycosylation Carbohydrates Nucleic acids 13
eIF5A Gene Regulation Platform: Targeting Cell Growth and Death: Broad Applications in Biotechnology These two proteins act as a biological switch to promote cell death or survival Cancer Amino Amino Lysine Hypusine Acid Acid Apoptosis Call Survival eIF5A eIF5A Death Targeted for cancer treatment (SNS01-T) 14
SNS01-T Gene Regulator Value Potential First in class therapeutic with three components siRNA to suppress pro-survival hypusine Proapoptotic plasmid expressing stable mutated eIF5A Polyethylenimine (PEI) forming nanoparticle for RNA/DNA Only gene therapy/siRNA in Multiple Myeloma Phase I/II Study Cohorts 1-3 completed, DLT reached in cohort 4 2/4 patients in Cohort 3 have SD after 6 weeks Most frequent AEs are infusion reactions and thrombocytopenia Results of Cohort 4 expected 2H 2014 Composition of matter and use patent claims 15
Experienced Management & Board of Directors Ronald A. Martell CEO, Sevion Vaughn Smider, M.D., Ph.D. CSO, Sevion Harlan Waksal, M.D. (chair) Founder, Imclone Systems Philip Frost, M.D. Chairman TEVA, CEO OPKO Christopher Forbes Vice President, Forbes Media, LLC John Braca Former partner SROne (Glaxo Smith-Kline) David Rector Principal David Stephen Group Steven Rubin COO, OPKO Health 16
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